Entering the European market from outside the European Union is a complex and lengthy process. Medical-device manufacturers have to familiarize themselves with EU-wide and country-specific knowledge and register their products in the respective data bases. It is mandatory for manufacturers to acquire the CE mark and to designate an authorized representative, as prescribed in European Directive 93/42/EEC. An authorized representative becomes the medium between the manufacturer and any authority within the EU. They also appear as point of primary contact on all documentation and product packaging.
We have acquired relevant information and built a thriving network in the field. Accordingly, we can advise you and serve as your EU Representative of choice.
- Company registration at the relevant authorities
- Product registration with the European Databank on Medical Devices (EUDAMED)
- Authorized European address
- Contact person for competent authorities
- Technical files storage
- Incident reporting (MEDDEV 2.12)
- Update on EU-issued news
Please ask for a non-binding offer via our Contact Form.